EpilepsyMicroEPINCT05335187
Hybrid Micro-macro Electrodes in Patients With Epilepsy
A study testing micro-macro electrode implantation in people with Epilepsy, run by Pierre Mégevand at 2 sites in Switzerland.
Trial summary
The aim of the MicroEPI study is to know whether it is possible to use safely a medical device (a micro-electrode) that allows recording the activity of neurons in the human brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- micro-macro electrode implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 30 Mar 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years old or older suffering from drug-resistant focal epilepsy.
- Candidate for epilepsy surgery.
- Requires evaluation with intracranial stereo-EEG electrodes.
- Able and willing to provide informed consent.
Who cannot join
- Any acute infection (e.g. fever, throat infection).
- Skin or scalp infection over the implantation site.
- Thin or fragile skull bones, which would prevent stereo-EEG electrodes from being anchored safely.
- Increased risk of infections, either from a medical condition or from immunosuppressant medication.
- Increased risk of bleeding, either from a medical condition or from antiplatelet or anticoagulant medication.
- Severe concomitant medical disease (including, but not limited to, cardiovascular, respiratory, renal or hepatic disease).
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- Severe concomitant psychiatric disease or major psychological distress.
- Women who are pregnant or breastfeeding during the study.
- Patients who have an implanted stimulation device (e.g. pacemaker, defibrillator, neurostimulator).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital Bern
Bern, Canton of Bern, 3010
Maxime Baud, MD, PhD, +41 31 664 12 22, maxime.baud@insel.ch
- Recruiting
Hôpitaux Universitaires de Genève
Geneva, CH, 1205
Pierre Mégevand, MD, PhD, +41 79 553 51 33, pierre.megevand@hcuge.ch
About this study
Official title: Hybrid Micro-macro Electrodes to Record the Activity of Single Neurons During Seizures in Patients Who Suffer From Epilepsy
The aim of the MicroEPI study is to know whether it is possible to use safely a medical device (a micro-electrode) that allows recording the activity of neurons in the human brain. Patients who suffer from drug-resistant epilepsy and who are candidates to epilepsy surgery to alleviate their condition sometimes require the implantation of intracranial EEG electrodes for a few weeks, in order to determine as best as possible which region of the brain to operate on. In the MicroEPI study, some of these electrodes will also comprise micro-electrodes, allowing us to record the activity of the patients' neurons during their epileptic seizures.
Read the detailed description
Epilepsy is a common disease of the brain that can be severe or even cause death. What we call epilepsy is a tendency to suffer from epileptic seizures, which themselves consist in symptoms (e.g. loss of consciousness, involuntary movements, abnormal sensations like hallucinations) caused by abnormally intense or synchronized activity of the brain's neurons. However, we still understand very poorly what exactly goes on at the level of neurons in the human brain during an epileptic seizure. This knowledge gap is due to the fact that the brain's neurons are very small structures and are very well protected by the skull, and are therefore hard to study in human beings. Gaining a better understanding of how neuronal activity goes awry during epileptic seizures could lead to better ways to treat this disease.
In the MicroEPI study, a medical device called micro-macro electrode (MME), manufactured by the company Dixi Medical (France), will be implanted in the brain of patients who must anyway receive intracranial EEG electrodes. These MME electrodes will replace one or a handful of conventional intracranial EEG electrodes. The implantation surgery will be performed in the operating room, under general anesthesia, by an experienced neurosurgeon. The electrodes will remain implanted for 2 to 4 weeks, with the exact duration depending on the time required for the clinical team caring for the patient to collect enough information on the patient's epilepsy. During the entire duration of the electrodes' implantation, the patient will remain hospitalized, and the electrical signals from their brain will be recorded continuously. At the end of this period, the electrodes will be explanted in the operating room. The safety of the MME electrodes, expressed in terms of the number of adverse events attributable to the MME, will be compared to current data on the safety of conventional intracranial EEG electrodes. The performance of the MME electrodes, in terms of the number of recorded neurons, will also be measured.
- Conditions
- Epilepsy
- Being tested
- micro-macro electrode implantation
- Keywords
- drug-resistant epilepsy, epilepsy monitoring unit, intracranial EEG, microelectrodes, neuronal recordings, epilepsy surgery
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-macro electrode implantationDevice
One or a handful of micro-macro electrodes are implanted for 2-4 weeks in patients undergoing epilepsy monitoring with intracranial EEG electrodes.
| Study group | Role | What they receive |
|---|---|---|
| micro-macro electrode | Experimental | In this single-arm, open-label study, all patients receive one or a handful of micro-macro electrode (MME) in place of conventional intracranial EEG electrodes. Receives: Device: micro-macro electrode implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (safety outcome)
Number of adverse and severe adverse events possibly, probably or definitely related to the study device
Measured: approximately 30 days
Secondary outcomes (2)
Device malfunctions (performance outcome 1)
Number of device malfunctions preventing the acquisition of microscopic electrophysiological signals
Measured: approximately 30 days
Number of neurons recorded (performance outcome 2)
Number of individual neurons recorded per micro-electrode
Measured: approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start30 Mar 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Mégevand
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Wyss Center for Bio and Neuroengineering
- Responsible party
- Sponsor-investigator, Pierre Mégevand, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335187
- Sponsor's protocol ID
- 2022-D0033
- Other IDs
- 194507, 10001031
- Acronym
- MicroEPI
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The neurophysiological data will be made available to the research community on an open scientific repository at the study's end.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Micro-macro Electrodes to Record the Activity of Single Neurons During Seizures in Patients Who Suffer From Epilepsy
- ClinicalTrials.gov ID
- NCT05335187
- Acronym / sponsor ID
- MicroEPI / 2022-D0033
- Conditions
- Epilepsy
- Keywords
- drug-resistant epilepsy, epilepsy monitoring unit, intracranial EEG, microelectrodes, neuronal recordings, epilepsy surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pierre MégevandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Wyss Center for Bio and Neuroengineering
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the MicroEPI study is to know whether it is possible to use safely a medical device (a micro-electrode) that allows recording the activity of neurons in the human brain. Patients who suffer from drug-resistant epilepsy and who are candidates to epilepsy surgery to alleviate their condition sometimes require the implantation of intracranial EEG electrodes for a few weeks, in order to determine as best as possible which region of the brain to operate on. In the MicroEPI study, some of these electrodes will also comprise micro-electrodes, allowing us to record the activity of the patients' neurons during their epileptic seizures.
Detailed description
Epilepsy is a common disease of the brain that can be severe or even cause death. What we call epilepsy is a tendency to suffer from epileptic seizures, which themselves consist in symptoms (e.g. loss of consciousness, involuntary movements, abnormal sensations like hallucinations) caused by abnormally intense or synchronized activity of the brain's neurons. However, we still understand very poorly what exactly goes on at the level of neurons in the human brain during an epileptic seizure. This knowledge gap is due to the fact that the brain's neurons are very small structures and are very well protected by the skull, and are therefore hard to study in human beings. Gaining a better understanding of how neuronal activity goes awry during epileptic seizures could lead to better ways to treat this disease.
In the MicroEPI study, a medical device called micro-macro electrode (MME), manufactured by the company Dixi Medical (France), will be implanted in the brain of patients who must anyway receive intracranial EEG electrodes. These MME electrodes will replace one or a handful of conventional intracranial EEG electrodes. The implantation surgery will be performed in the operating room, under general anesthesia, by an experienced neurosurgeon. The electrodes will remain implanted for 2 to 4 weeks, with the exact duration depending on the time required for the clinical team caring for the patient to collect enough information on the patient's epilepsy. During the entire duration of the electrodes' implantation, the patient will remain hospitalized, and the electrical signals from their brain will be recorded continuously. At the end of this period, the electrodes will be explanted in the operating room. The safety of the MME electrodes, expressed in terms of the number of adverse events attributable to the MME, will be compared to current data on the safety of conventional intracranial EEG electrodes. The performance of the MME electrodes, in terms of the number of recorded neurons, will also be measured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro-macro electrode | Experimental | Device: micro-macro electrode implantationIn this single-arm, open-label study, all patients receive one or a handful of micro-macro electrode (MME) in place of conventional intracranial EEG electrodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18 years old or older suffering from drug-resistant focal epilepsy.
- Candidate for epilepsy surgery.
- Requires evaluation with intracranial stereo-EEG electrodes.
- Able and willing to provide informed consent.
Key exclusion criteria (9 listed)
- Any acute infection (e.g. fever, throat infection).
- Skin or scalp infection over the implantation site.
- Thin or fragile skull bones, which would prevent stereo-EEG electrodes from being anchored safely.
- Increased risk of infections, either from a medical condition or from immunosuppressant medication.
- Increased risk of bleeding, either from a medical condition or from antiplatelet or anticoagulant medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro-macro electrode implantationOne or a handful of micro-macro electrodes are implanted for 2-4 weeks in patients undergoing epilepsy monitoring with intracranial EEG electrodes. | Device | micro-macro electrode |
Primary outcome
Adverse events (safety outcome)
Time frame: approximately 30 days
Number of adverse and severe adverse events possibly, probably or definitely related to the study device
2 secondary outcomes
Device malfunctions (performance outcome 1)
Time frame: approximately 30 days
Number of neurons recorded (performance outcome 2)
Time frame: approximately 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. The neurophysiological data will be made available to the research community on an open scientific repository at the study's end.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-macro electrode implantation in people with Epilepsy, run by Pierre Mégevand at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Mégevand, MD, PhD (+41 22 379 53 88, pierre.megevand@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (safety outcome) (time frame: approximately 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.